A specification is the agreed definition of an acceptable lot: every parameter, every limit, in writing, signed by both sides. It governs all future deliveries until revised, and the Certificate of Analysis for each lot is judged against it. Write it well and QA becomes a simple pass/fail; write it loosely and every lot becomes a negotiation.
The anatomy of a good spec
| Section | What to state | Why it matters |
|---|---|---|
| Identity | Botanical (Latin binomial), plant part, extraction ratio or native/standardised | Fixes what the material actually is |
| Marker / assay | Named marker(s), target %, method (e.g. HPLC), and total vs specific | This is your label claim — make it unambiguous |
| Physical | Appearance, colour, odour, solubility grade, particle size / mesh, carrier & % | Decides whether it works in your format |
| Purity — chemical | Loss on drying, ash, residual solvents, heavy metals limits | Safety and stability |
| Purity — microbial | Total plate count, yeast & mould, pathogens (E. coli, Salmonella) | Safety to your market's limits |
| Contaminants | Pesticides, mycotoxins/aflatoxins where relevant | Botanical-specific risks |
| Documentation | COA per lot, allergen/GMO/BSE-TSE statements, SDS | What must accompany every shipment |
| Logistics | Packaging, lot coding, shelf life, storage conditions | Protects the material in transit and on your shelf |
Words that cause disputes
- 'High potency' — meaningless without a number and a method. Replace with a limit.
- 'Pure' — pure of what? State the actual purity parameters and limits.
- 'Natural / full-spectrum' — a story, not a testable value. Pair it with something a method can confirm.
- 'Approx.' on a critical parameter — decide if it is a limit or delete it.
- A marker % with no method — always attach the analytical method and the reference basis.
Make it a two-way document
A specification works best when it is agreed, not imposed. Send your draft, let the manufacturer flag anything unrealistic for that botanical (some markers simply do not reach certain levels; some limits are tighter than the plant allows), and settle on a spec both sides can actually hold every lot. A spec the supplier quietly knows they cannot meet is worse than no spec at all.
Once agreed, freeze it, version it, and reference the version on every purchase order. From then on, quality control is simply checking each lot's COA against a document both sides already signed — which is exactly where you want it.
Apply this to your sourcing
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